Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain

November 22, 2024 updated by: Ali Abdelmoniem Ali Hassanien, Cairo University

The purpose of the study is to investigate the effect of lateral wedged insoles with subtalar strapping in genu varum with medial compartment knee pain on:

  1. Space between knees (measured by vernier calipers)
  2. Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
  3. Pain level (Measured by VAS)
  4. Hind foot angle (measured by long axial hindfoot alignment view)
  5. Functional outcome (measured by the lower extremity function scale)
  6. Functional performance (measured by the 6 minute walk test)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Genu varum is known as one of the most common lower limb abnormalities. Genu varum is reported to occur 15 to 20% in the whole population. In most cases, this deformity occurs between tillage damage and degeneration in the medial compartment of the knee joint in the long term, because of the imposed imbalanced force on medial and lateral compartments of knees.

Incidence of rachitic genu varum in preschool children: A more recent study from 2016 estimated the incidence of vitamin D deficient rachitic genu varum among preschool children in Egypt, finding it to be 13.1% of all children's orthopaedic diseases at the National Institute of Neuromotor System.

Prevalence of lower limb deformities in primary school students: A 2021 study reported a much lower prevalence of genu varum (0.09%) among primary school students in Egypt. This suggests that the condition may be more prevalent in younger children and decrease in severity with age.

Surgical treatments, such as high tibial osteotomy and total knee arthroplasty (TKA) have been performed. Although this type of surgery has provided successful clinical results, it is often costly for the patients and it forces them to get over complications. In particular, more than 500,000 cases of TKA are annually performed in the US, and approximately three billion dollars are spent on TKA. Alternatives to surgical treatment are required to lighten the patient's burden and the medical costs.

lateral wedged insole significantly reduces the knee varus moment during walking compared to the barefoot condition with no insole. In particular, the strapping insole reduces the varus moment more than the lateral wedged insole alone in moderate OA.

Exercises of correcting genu varum might have positive effects on changes in hip joint angle, Q angle, and knee space distance, and lower limb deformity not by structural causes but by muscular imbalance might be corrected via consistent exercises.

The results of this study could potentially inform the treatment approach for individuals with medial compartment knee pain caused by genu varum. Also provides a non-invasive and cost-effective alternative to managing knee pain, which can improve the quality of life for individuals suffering from this condition. Additionally, this study adds to the body of knowledge on the effectiveness of corrective orthoses in managing musculoskeletal disorders.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abeer Abdulrahman, PhD

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy, Cairo University
        • Contact:
        • Contact:
          • Abeer Abdulrahman, PhD
        • Principal Investigator:
          • Magda Gayed, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both genders aged 20-60.
  • Patients with medial compartment pain. Pain level of 3 or more on the VAS.
  • Patients with varus deformity are defined as those Those whose femorotibial angle measures 5-10 degrees of genu varum on long film weight bearing x-ray.
  • Patients with grade one O.A. on Kellgren-Lawrence classification system or without O.A.
  • BMI less than 35
  • Patients with decompensated hind foot (hind foot varus)

Exclusion Criteria:

  • Patients already wearing custom wedged insoles.
  • Patients with other inflammatory conditions like rheumatoid arthritis or systematic inflammatory arthritis.
  • Patients with central or peripheral nervous system disease.
  • Any previous surgical procedure to the knee joint.
  • Patients who are unable to walk without assistance (cane or a walker).
  • Pregnancy
  • Uncooperative patient types due to mental disorders or others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corrective exercise protocol + Lateral wedged insoles with subtalar strapping
They will receive the corrective exercise protocol in addition to the lateral wedged insoles with subtalar strapping for 12 weeks.
Other: Corrective exercise protocol
The program requires 60 minutes consisting of a ten-minute warm-up, a forty-minute Thera-band exercise, and a ten-minute cool-down. Thera-band exercises are to improve the external rotators, and the extensors and for strengthening the quadriceps and the gluteus. A set consists of 15 reps, each of the exercise methods consisted of three sets.
Other: Lateral wedged insoles with subtalar strapping
A silicon rubber 10 mm lateral wedge has a 10 mm lateral elevation and a 75 mm width, which has an approximately 7.6 inclination. This silicon rubber material is usually used for cosmetic remodeling and has a natural form-fit to the skin. The 75 mm width silicon rubber is scaphoid shaped and it is suitable for attachment to a barefoot of all of the subjects. The rational for using this inclination is that 7.6 is approximately the median between 5 and 10. Patients will be instructed to use the wedge in an appropriate shoe (not high heels or narrow-toed shoes), 1 h a day during the first week. The duration of use gradually will be increased to the minimum of 8 h a day.
Active Comparator: Corrective exercise protocol
They will receive the same corrective exercise protocol alone for 12 weeks.
Other: Corrective exercise protocol
The program requires 60 minutes consisting of a ten-minute warm-up, a forty-minute Thera-band exercise, and a ten-minute cool-down. Thera-band exercises are to improve the external rotators, and the extensors and for strengthening the quadriceps and the gluteus. A set consists of 15 reps, each of the exercise methods consisted of three sets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance between knees using vernier calipers
Time Frame: 12 weeks
To measure the distance between the participants' knees, we have them put both feet together, so that both malleolus bones were together, and measured the space between the tibia and medial condyle using vernier calipers.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of genu varum deformity measured by long film weight bearing X-Ray
Time Frame: 12 weeks
The femorotibial angle in the frontal plane is the angle formed by the intersection of anatomical axes of the femur and tibia. In normal knee alignment, there is an approximately 5°-7° valgus femorotibial angle.
12 weeks
Pain level measured by the visual analogue scale (VAS)
Time Frame: 12 weeks
The VAS is a uni-dimensional measure of pain intensity.It is a continuous scale that comprises of a horizontal line of 10 cm in length. The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). A higher score indicates greater pain intensity.
12 weeks
Hind foot angle measured by long axial hindfoot alignment view
Time Frame: 12 weeks
The film cassette is lying on the floor and the subject is standing on the film cassette. The inclination angle of the beam is 45° to the floor.
12 weeks
Functional outcome measured by lower extremity function scale (LEFS)
Time Frame: 12 weeks
The lower extremity function scale (LEFS) is a region specific outcome measure that was designed to assess activity limitations due to musculoskeletal disorders of the lower extremity. LEFS has 20 items each scored on 0-4 Likert scale and the overall score on the scale is produced by summing scores on all items. LEFS score range from 0 to 80 with higher score indicating better functional ability.
12 weeks
Functional performance measured by the 6 minute walk test
Time Frame: 12 weeks
The patients will walk as far a distance as possible within 6 minutes. They will be instructed to walk as fast as possible, but running or jogging will not be allowed. Standardized encouragement and updates on the remaining time for the 6MWT will be provided at each minute mark. When the patient turns around a cone (set 30 meters away), it will be marked on a worksheet. After 6 minutes, the patients will be told to stop immediately, and a small piece of tape will be placed just in front of their shoes. The additional distance covered (in the final 30-meter stretch) will be measured to the nearest centimeter. Finally, the total distance walked by each patient in 6 minutes will be calculated and recorded. Patients will be permitted to rest by standing or leaning against the wall during the test trial, but the timer will continue to run.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Abeer Abdulrahman, PhD, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

October 12, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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